Author + information
- Roel J.R. Snijder, MD†,
- Martijn C. Post, MD, PhD†∗ (, )
- Thijs B.J.M. Mulder, MD†,
- Ben J. Van den Branden, MD, PhD‡,
- Juriën M. Ten Berg, MD, PhD† and
- Maarten J. Suttorp, MD, PhD†
- †Department of Cardiology, St. Antonius Hospital, Nieuwegein, the Netherlands
- ‡Department of Cardiology, Amphia Hospital, Breda, the Netherlands
- ↵∗Department of Cardiology, St. Antonius Hospital Nieuwegein, Koekoekslaan 1, 3435 CM Nieuwegein, the Netherlands
To the Editor:
A relatively high percentage of residual shunting was present 6 months after patent foramen ovale (PFO) closure using a bioabsorbable device (1). The presence of moderate to severe residual shunt might increase the risk of cryptogenic stroke (2,3). Despite the fact that the device is currently off the market, many patients were treated worldwide, and little is known about the long-term efficacy and safety. We report the long-term safety and efficacy of the bioabsorbable device used for percutaneous PFO closure.
As reported previously, between November 2007 and January 2009, all consecutive patients who underwent a percutaneous closure of a symptomatic PFO with a bioabsorbable device (Biostar, NMT Medical, Boston, Massachusetts) were included (1). Intracardiac echocardiography was used during most procedures.
After discharge, routine follow-up was scheduled at 1, 6, 12, and 24 months, using contrast transthoracic echocardiography (cTTE). The residual shunt rate was classified as none, minimal, moderate, and severe, as described previously (1).
Continuous variables with normal distribution are presented as mean ± SD. Residual shunt sizes at different time points were compared using the Wilcoxon signed rank test. Univariate statistical analysis, using a Cox proportional hazards model, was used to identify risk factors for residual shunting and adverse events after PFO closure. All statistical analyses were performed using SPSS software version 17.0 (SAS Institute, Cary, North Carolina).
Percutaneous PFO closure with the bioabsorbable device was performed in 62 consecutive patients (55% women; mean age: 47.7 ± 11.8 years). Ninety-four percent of the patients had experienced a cryptogenic stroke or transient ischemic attack (TIA) and were referred by a neurologist. Eight patients (12.9%) had a history of supraventricular tachycardia (SVT).
These data were previously reported (1). In summary, device implantation was successful in 60 patients (96.8%), and there were complications in 2 patients (3.2%). A minimal vascular surgical intervention was needed to retrieve the device at the femoral vein in both. A small groin hematoma was present in 6 patients (9.7%).
There were no procedure-related deaths, major adverse cardiac events, or stroke between discharge and 2-year follow-up. In 7 patients (11.3%), new SVTs were diagnosed in the first month after closure, and 1 (1.6%) was diagnosed between 1- and 6-month follow-up. Patients with known rhythm disorders did not report an increase in SVT episodes after PFO closure. A TIA recurred in 2 patients, both within the first year after closure. No device-related complications or recurrent ischemic cerebral events occurred between 12- and 24-month follow-up.
One day after closure, a residual shunt was present in 60% (36 of 60 patients): minimal in 31.7%, moderate in 20%, and severe in 8.3% of patients. At 12-month follow-up, in total, 25% of patients (14 of 56 patients) had a residual shunt: minimal in 17.9%, moderate in 5.4%, and severe in 1.8% (p = 0.76 compared with 6-month follow-up as reported previously) (1). The 4 patients missing from this follow-up had no residual shunt at 6 months. At 24-month follow-up, 30.9% (17 of 55 patients) had a residual shunt (21.8% minimal, 9.1% moderate, and 0.0% severe; p = 0.37) compared with 12-month follow-up. At 24-month follow up, cTTE was not performed in 4 patients, and 1 patient was lost to follow-up. Three of these 4 patients were the same as described at 12-month follow-up. The other 2 patients had no residual shunt at 12-month follow-up. All these patients had no new symptoms or complications at 24-month follow-up. Between 12- and 24-month follow-up, the residual shunt size remained the same in 8 patients and both increased and decreased by 1 level in 1 patient. Three patients with a minimal residual shunt at 12-month follow-up had no shunt at 24-month follow-up. However, 6 patients without a shunt at 12-month follow-up experienced a minimal residual shunt at 24-month follow-up. No predictors of residual shunt could be identified. Efficacy data are shown in Figure 1.
The bioabsorbable device has a high residual shunt rate of 30%, even 2 years after closure. This implies that this device was insufficient for percutaneous closure of a PFO, and long-term follow-up seems to be necessary.
- American College of Cardiology Foundation
- Van den Branden B.J.,
- Post M.C.,
- Plokker H.W.,
- ten Berg J.M.,
- Suttorp M.J.
- Cabanes L.,
- Mas J.L.,
- Cohen A.,
- et al.